New Fill use in US

I noticed you're also a lawyer. Could you clarify your position on New Fill. There seem to be a variety of opinions as to whether a US physician can give it to a patient.

Response from Dr. Boyle

There seem to be a lot of opinions on this, but some things are clear:
(1) New-Fill has never been approved by the US FDA.
(2) The US FDA found that New-Fill is a Class III device under the Federal Food, Drug and Cosmetic Act (the "Act") and barred its importation under SEC 801 (a) (3) of that Act.
(3) Absent certain exceptions, none of which appear applicable here, under the Act and other regulations, US physicians are barred, by law, from using or distributing drugs or medical devices that are not approved by the US FDA.
(4) The Act (available at the FDA website, www.FDA.gov), and other Federal and State regulations, provide penalties, both civil and criminal, for violation of their provisions.
As a physician who cares for HIV-infected patients, some of whom have lipoatrophy, I hope that New-fill is approved, and soon, by the FDA. But, until it is, the use of New-fill appears to be prohibited under the Act. For those in need now, all I can say is that there are some physicians who are giving it, and risking action against them by the FDA and perhaps their own state's licensing agency, and that it is available in other countries, including many of the European countries.
I am aware that some claim that the FDA has granted some physicians in the US an "exemption" or "authority" to use New-Fill. I'd be curious to know if that is true, since I am unaware of any provision under the Act that would provide such an exception for New-Fill, and, if so, exactly what exemption or authority the FDA granted and the legal basis it cited for doing so.
I hope this helps clarify the issue. For further information I urge all interested to go to the FDA website, the address for which is provided above

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